Rollover Study to Provide Continued Access to Napabucasin for Patients Enrolled in Boston Biomedical-sponsored Protocols

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Sumitomo Pharma America, Inc.
Study ID
NCT04299880
Phase
PHASE1
Status
Completed

Conditions

  • Oncology

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Napabucasin — DRUG
    Oral
  • Nab-paclitaxel — DRUG
    Intravenous
  • Gemcitabine — DRUG
    Intravenous
  • Nivolumab — DRUG
    Intravenous
  • Paclitaxel — DRUG
    Intravenous
  • Irinotecan — DRUG
    Intravenous
  • Leucovorin — DRUG
    Intravenous
  • 5Fluorouracil — DRUG
    Intravenous
  • Bevacizumab — DRUG
    Intravenous

Study Details

This is an open-label, multi-center, multi-national, non-randomized rollover study designed to allow continued access to napabucasin for patients who have participated in a Boston Biomedical-sponsored study and are being treated with napabucasin (monotherapy or combination) and who are deriving continued clinical benefit in the parent study at the time of closure.

Key Dates

Start date
Feb 24, 2020
Status verified
Nov 2023
Primary completion
May 15, 2021
Completion
May 30, 2021

Study Design

Enrollment
7 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Napabucasin monotherapy
    Patients in this arm will receive napabucasin administered orally, twice daily
  • Other: Napabucasin in combination with Gemcitabine and Nab-paclitaxel
    Patients in this arm will receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously once weekly, on 3 of every 4 weeks.
  • Other: Napabucasin in combination with Nivolumab
    Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly nivolumab 3mg/kg administered intravenously over 60 minutes.
  • Other: Napabucasin in combination with paclitaxel
    Patients in this arm will receive napabucasin administered orally, twice daily in combination with weekly paclitaxel administered intravenously once weekly, on 3 of every 4 weeks.
  • Other: Napabucasin in combination with FOLFIRI
    Patients in this arm will receive napabucasin administered orally, twice daily in combination with biweekly FOLFIRI. Addition of bevacizumab, per Investigator choice, will be permissible.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: From first dose until 30 days following last dose of napabucasin ]

Locations (3)

FacilityCityStateZIPSite coordinators
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
Maine Center for Cancer MedicineScarboroughMaine04074-
OHSU Knight Cancer InstitutePortlandOregon97239-

Find similar trials in Atlanta, GA

By research site
Winship Cancer Institute, Emory University· Atlanta, GAMaine Center for Cancer Medicine· Scarborough, MEOHSU Knight Cancer Institute· Portland, OR

Related Studies